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Generated: October 17, 2018

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Bupropion hydrobromide - Generic Drug Details

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What are the generic sources for bupropion hydrobromide and what is the scope of bupropion hydrobromide freedom to operate?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Pharmacology for bupropion hydrobromide
Synonyms for bupropion hydrobromide
2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide
905818-69-1
AK-75761
AKOS015917698
Aplenzin
Aplenzin ER
bupropion HBr
Bupropion hydrobromide (USAN)
Bupropion hydrobromide [USAN]
CHEMBL1201735
D07938
I14-9201
SCHEMBL636116
WSTCENNATOVXKQ-UHFFFAOYSA-N
Tentative approvals for BUPROPION HYDROBROMIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up522MGTABLET, EXTENDED RELEASE; ORAL
➤ Sign Up➤ Sign Up174MGTABLET, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for bupropion hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for bupropion hydrobromide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2000 00018 Denmark ➤ Sign Up PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2017 00062 Denmark ➤ Sign Up PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
2017000109 Germany ➤ Sign Up PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
C/GB00/019 United Kingdom ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
0918 Netherlands ➤ Sign Up PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
/2000 Austria ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Moodys
Argus Health
Julphar
Fish and Richardson
Merck
Farmers Insurance
Healthtrust

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